181 results
Primary objectives: - Overall: Improvement of event-free survival (EFS) probabilities in childhood relapsed ALL - Randomization 1: EFS of Arm A (ALL-REZ BFM 2002) versus B (ALLR3) in SR patients - Randomization 2: Influence of epratuzumab…
We want to examine the effect of the antihistamine Ebastine on abdominal pain and other symptoms associated with IBS and the quality of life. Through this research we would like to emphasize that this study primarily focuses on improvements of the…
Currently, there are no curative treatment options for patients with Waldenstrom*s macroglobulinemia (WM) and there is no consensus on standard first line or relapse treatment. The proteasome inhibitor bortezomib has shown efficacy in WM, but is…
Primary:• To evaluate the safety of ORGN001 (formerly ALXN1101) over the first 6 months of treatmentSecondary:• To characterize the pharmacokinetics (PK) of increasing doses of ORGN001 (formerly ALXN1101) • To evaluate the effect of ORGN001 (…
The objective of this study is to assess the efficacy and safety of radium-223 dichloride in subjects with human epidermal growth factor receptor 2 negative (HER2 negative), hormone receptor positive breast cancer with bone metastases treated with…
The co-primary objectives of this study are as follows:* To evaluate the effect of presatovir (GS-5806) on RSV viral load and development of lower respiratory tract complication (LRTC) in RSV positive autologous or allogeneic HCT recipients with…
This safety study in subjects in the early (predementia) AD spectrum is performed to investigate primarily the safety and tolerability of JNJ-54861911 during 6 months of treatment.
To study whether either early 18F-FDG or 18F-FLT PET is superior in detecting response to treatment with the combination of vemurafenib plus cobimetinib (GDC-0973) compared to standard response assessment with CT and to evaluate whether, and which,…
The primary objectives of the study are as follows:• To investigate the effect of recAP on renal function and related clinical parameters in patients with SA-AKI.• To determine the therapeutic dose(s) of recAP to support the pivotal Phase 3 program.…
2. OBJECTIVES2.1 SAFETY OBJECTIVESThe safety objectives for this study are as follows:* To evaluate the safety of MHAA4549A in combination with oseltamivir compared with placebo and oseltamivir in patients with severe influenza A, focusing on the…
The primary objective is to assess the effects on amyloid plaque burden of administration of VX-745 for 12-weeks, as assessed by Dynamic 11C-PiB (Carbon-11 labeled Pittsburgh Compound B) PET Amyloid Scanning in patients with Mild Cogntitive…
To assess the safety and tolerability of multiple doses of PQ912 compared with placebo in subjects with early stage of Alzheimers Disease.
The primary objective of this study is to evaluate the effects ofpresatovir (GS-5806) on RSV viral load in RSV-positive adults hospitalizedwith acute respiratory infectious symptoms.The secondary objectives of this study are to evaluate:- The effect…
Objectives: To evaluate whether aerobic exercise leads to clinically relevant improvements in 1) motor and 2) non-motor symptoms as well as quality of life and physical fitness.
Primary objectivePhase 1: To assess the safety and tolerability of Nab-paclitaxel added to oxaliplatin and capecitabine at their currently optimal doses.Phase 2: To determine the anti-tumor activity of Nab-paclitaxel when co-administered with…
The purpose of this study is to investigate the effectiveness and safety of riociguat (BAY 63-2521) in patients with diffuse cutaneous systemic sclerosis.
Primary Study Objective: The primary objective of this study is to assess the efficacy of laquinimod 0.5 mg and 1.0 mg qd in patients with HD after 12 months of treatment using the UHDRS-TMS.Secondary Study Objectives:• To assess the effect of…
1. Normalization of the abnormal serum TH parameters and thereby improving the clinical condition of the AHDS patients2. Observation of changes in cognitive and motor function.
This is a prospective phase II non-randomized single-center study in patients with LAPC. Patients are first treated with up to 8 cycles of FOLFIRINOX, followed by stereotactic radiotherapy for a total dose of 40 Gy in 5 fractions. Due to the known…
To investigate different dosages of 4 weeks oral Eubacterium hallii treatment on safety and efficacy parameters.